Wound retractor

ABSTRACT

An incrementally adjustable wound retractor ( 100 ), having a first ring ( 102 ) with a diameter greater than the desired diameter of the wound incision. A second ring ( 104 ), having an annular axis and a diameter greater than the desired diameter of the wound incision. A flexible sleeve ( 106 ), disposed in a generally cylindrical form between the first and second rings ( 102, 104 ), the second ring may be rolled over itself and around the annular axis to provide a sleeve with a radical retraction force sufficient to stretch the incision to the desired diameter.

This is a non-provisional application claiming the priority ofprovisional application Ser. No. 60/386,159, filed on Jun. 5, 2002,entitled “Omega Wound Retractor,” and the priority of provisionalapplication Ser. No. 60/415,351, filed on Oct. 2, 2002, entitled “WoundRetractor,” both of which are fully incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention generally relates to medical devices and, morespecifically, to an improved wound retractor providing ease ofincremental retraction and alignment to fit a wide range of incisionsizes, including audible and tactile feedback to the user.

2. Discussion of the Prior Art

Surgery typically involves making an incision large enough toaccommodate a surgeon's hand and/or multiple instruments. The incisionmust be kept clean since it is susceptible to infection if touched bydiseased body parts and/or contaminated instruments. As such, woundprotectors are available to insure that exposed sides of an incision arecovered and protected from contaminants. A common deficiency of woundprotectors is their lack of ease of retraction adjustability andstability. U.S. Pat. Nos. 5,524,644 and 6,382,211, both to Crook,attempt to address this deficiency with a wound protector including anouter ring having an oblate cross-section and opposed flat surfaces thatallegedly provide retraction adjustability and stability. The oblatedesign of the outer ring of Crook, however, provides only limitedincremental retraction and can be difficult to twist or turn. Inaddition, the Crook design does not provide for an audible feedback tothe user. Accordingly, there is a need in the art for an improved woundretractor that can be easily retracted to fit a wide range of incisionsizes. The improved wound retractor preferably provides audible and/ortactile feedback to the user during retraction.

SUMMARY OF THE INVENTION

An incrementally adjustable wound retractor for sealing edges of asurgical incision and forming an opening in a patient's body cavity, thewound retractor comprising an inner ring, an outer ring and a flexiblesleeve connecting the inner ring and the outer ring. The wound retractorprovides a path for a surgeon to insert his hand and/or instrumentsthrough the opening formed by the wound retractor. The wound retractoris incrementally adjustable to fit a wide range of incision sizes. Thewound retractor is installed or placed in a body cavity such that theinner and outer rings expand around inner and outer edges of theincision. Any portion of the flexible sleeve extending outside theincision can be easily rolled onto the outer ring to tightly seal thesides of the wound. The outer ring is preferably shaped to provideaudible and/or tactile feedback to the user. In particular, the outerring includes surfaces that are easy to grip and turn to allow the userto manually turn the outer ring and roll up the flexible sleeve withease. The outer ring may be solid or include a lumen with a rod placedtherein to provide audible signal to the user as the outer ring isturned.

These and other features and advantages of the invention will becomemore apparent with a discussion of preferred embodiments in reference tothe associated drawings.

DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a cutaway side view and an isometric view of anincrementally adjustable wound retractor in accordance with anembodiment of the invention;

FIGS. 2 a-2 d illustrate the retraction of the outer ring of the woundretractor of FIG. 1 to fit a desired incision;

FIG. 3 is a longitudinal cross-section view of the wound retractor ofFIG. 1 taken along line A-A;

FIG. 4 illustrates the wound retractor of FIG. 1 installed in anincision;

FIG. 5 is a cross-section view of a hollow tube of an outer ring of awound retractor in accordance with a second embodiment of the invention;

FIG. 6 is a cross-section view of an inner rod of the outer ring of thewound retractor in accordance with the second embodiment of theinvention;

FIG. 7 illustrates a cutaway side view of an incrementally adjustablewound retractor in accordance with the second embodiment of theinvention;

FIG. 8 illustrates the retraction and alignment of the outer ring to fita desired incision size in accordance with the second embodiment of theinvention;

FIG. 9 illustrates the wound retractor of FIG. 7 installed in anincision;

FIG. 10 illustrates a longitudinal cross-section view of an outer ringincluding a wire in accordance with a third embodiment of the invention;

FIGS. 11 and 12 illustrate the rolling of the outer ring to fit adesired incision size in accordance with the third embodiment of theinvention;

FIG. 13 is a three-dimensional cross-section view of the wound retractorof FIG. 10;

FIG. 14 is a three-dimensional image of the hollow tube of the outerring of the wound retractor in accordance with the second embodiment ofthe invention;

FIG. 15 is a three-dimensional image of the inner rod of the outer ringof the wound retractor in accordance with the second embodiment of theinvention;

FIG. 16 is a cross-section view of the hollow tube and inner rodcoaxially joined in accordance with the second embodiment of theinvention;

FIGS. 17 a-17 e illustrate cross-section views of additional embodimentsof the outer ring of the invention;

FIGS. 18 a-18 l illustrate cross-section views of additional embodimentsof the hollow tube and inner rod of the outer ring of the invention;

FIGS. 19 a-19 g illustrate cross-section views of additional embodimentsof the outer ring of the invention having generally prolatecross-sections;

FIGS. 20 a-20 g illustrate cross-section views of additional embodimentsof the outer ring of the invention having generally prolatecross-sections and including lumens;

FIGS. 21 a-21 e illustrate cross-section views of additional embodimentsof the outer ring of the invention having generally oblatecross-sections;

FIGS. 22 a-22 e illustrate cross-section views of additional embodimentsof the outer ring of the invention having generally oblatecross-sections and including lumens;

FIG. 23 a illustrates a cross-section view of another embodiment of theouter ring of the invention having a triangular cross-section;

FIG. 23 b illustrates a cross-section view of the outer ring of FIG. 23a further including a lumen;

FIG. 24 a illustrates a cross-section view of another embodiment of theouter ring of the invention having a cross-section comprising an oddnumber of sides such as a pentagon;

FIG. 24 b illustrates a cross-section view of the outer ring of FIG. 24a further including a lumen;

FIGS. 25 a-25 b illustrate different processes of forming the outer ringof the invention;

FIG. 26 illustrates an axial cross-section view of a surgical accessdevice with a slightly modified gel cap and/or abdominal base inaccordance with another embodiment of the invention;

FIG. 27 is an axial cross-section view of a surgical access device inaccordance with another embodiment of the invention;

FIGS. 28-30 illustrate additional exemplary embodiments of the inventionhaving modifications that could be made to the gel cap and/or theabdominal base so that the surgical access device can be used with thewound retractor;

FIG. 31 illustrates a perspective view of a base of a surgical accessdevice in accordance with another embodiment of the invention;

FIG. 32 is an axial cross-section view of the embodiment illustrated inFIG. 31;

FIGS. 33 and 34 illustrate a base of a surgical access device inaccordance with another embodiment of the invention having at least onetoggle or latch adapted to fit a corresponding cap ring; and

FIGS. 35 and 36 illustrate a base of a surgical access device inaccordance with another embodiment of the invention having a raised wallon an inner diameter and adapted to fit a corresponding cap ring.

DESCRIPTION OF PREFERRED EMBODIMENTS AND BEST MODE OF THE INVENTION

FIG. 1 illustrates a wound retractor 100 in accordance with a firstembodiment of the invention. The wound retractor 100 comprises adouble-tube outer ring 102, an inner ring 104, and a distensible sleeve106 connecting the outer ring 102 and the inner ring 104. The sleeve 106may be attached to the outer ring 102 and the inner ring 104 by heatseal or adhesive. The outer ring 102 and the inner ring 104 arepreferably made of a material of sufficient hardness to retain theirshape after twisting and rolling of the rings. That is, the materialmust be compliant enough to allow the outer ring 102 to be turned aroundits annular axis as further described below and illustrated in FIGS. 2a-2 d. The shape of the outer ring 102 affects both its ability to gripand to provide stability during and after adjustment. The sleeve 106 ispreferably made of a material that is flexible and impermeable to fluidsand bacteria. The double-tube outer ring 102 preferably comprises afirst circular tube 108 and a second circular tube 110 joined togetherby a small web 112. Each of the circular tubes 108 and 110 may be solidor include a lumen.

FIGS. 2 a-2 d illustrate the retraction and adjustment of the outer ring102 to fit an incision. In accordance with the invention, the woundretractor 100 is axially adjustable in increments. In particular, theupper end of the sleeve 106 can be wrapped around the outer ring 102 soas to tightly seal the sides or edges of the incision. The unique shapeof the outer ring 102 provides for an easy snap action when rolled aboutitself. The outer ring 102 also provides for incremental shortening ofthe sleeve 106 and for stability after installation. FIG. 3 illustratesa longitudinal cross-section view of the wound retractor 100 taken alongline A-A.

FIG. 4 illustrates a process of installing the wound retractor 100 in awound opening 400. An incision in the shape of a slit is first made in apatient's body, e.g., the abdominal wall. The inner ring 104 and thesleeve 106 are then manually inserted into body cavity 402 through theincision with the outer ring 102 remaining external to the body cavity402. Once the inner ring 104 is within the body cavity 402, it expandsaround the inner surface of the incision so as to be generally parallelto the abdominal wall. The sleeve 106 provides a channel from theoutside to the inside of the body cavity 402. The outer ring 102initially rests above the abdominal wall around the wound opening 400.Since the upper end of the sleeve 106 is connected to the outer ring102, the sleeve 106 can be drawn upwards and radially outward or inward,thereby drawing the inner ring 104 tightly against the inner surface ofthe abdominal wall. Moreover, the intermediate portion of the sleeve 106is drawn tightly against the sides and edges of the wound opening 400,thereby retracting the adjacent tissue and producing a tightly sealedopening in the body cavity 402. That is, the sleeve 106 contacts theentire wound surface and protectively covers the same and seals it fromcontamination and infection. Depending on the size and depth of theincision, the user can roll up the sleeve 106 by gripping thedouble-tube outer ring 102 and turning it in a direction 200 asillustrated in FIGS. 2 a-2 c until the sleeve 106 abuts the outer edgeof the wound opening 400. It should be appreciated that the outer ring102 can be turned around its annular axis in either an outward or inwarddirection to roll the sleeve 106.

The outer ring 102 has a unique and novel double-tube configurationwherein through simple manipulation of forcing a first tube in a firstdirection and a second tube in a second direction, the positions of thefirst and second tubes can be inverted resulting in fast and easyturning of the tubes as illustrated in FIGS. 2 a-2 d. In one embodimentof the invention, the outer ring 102 is rotated by pushing the bottomtube or second circular tube 110 inward while pulling the top tube orfirst circular tube 108 outward (see FIG. 2 a). The combination of theabove steps results in inversion of the first and second circular tubesas illustrated in FIG. 2 d. That is, the outer ring 102 can be rotatedin 180° turns thereby retracting the sleeve 106. The above process canbe repeated until a desired compression or wound opening is achieved.

An advantage of the invention is it provides for an easier, faster andhigher retraction rate than that known in the prior art, therebyresulting in less traumatic effects to the patient. Another advantage ofthe invention is it provides tactile gripping and incremental rolling ofthe sleeve about the outer ring. In the above description, the first andsecond tubes of the outer ring are in a vertical position but it shouldbe appreciated that the first and second tubes may be in differentpositions relative to one another such as a horizontal position.

In another embodiment of the invention, a small wire 302 such as astainless steel wire is placed inside a lumen of the double-tube outerring 102 (see FIGS. 3 and 10-13) so as to provide an audible signal asthe outer ring 102 is turned. That is, as the double-tube outer ring 102is turned, the wire 302 deflects against the tubing wall so as toprovide an audible sound feedback to the user. Another feature of thewire 302 is it provides retraction stability to the wound retractor 100.

After surgery, the wound retractor 100 may be retrieved by grabbing theinner ring 104 and the sleeve 106 and pulling them through the woundopening 400. The use of the sleeve 106 and the ease of retracting theouter ring 102 provide higher compression between the inner and outerrings. As a result, the wound retractor 100 of the invention providesincremental adjustability to fit a wide range of incision sizes andisolates and protects the wound from bacterial infection as the diseasedbody parts and contaminated instruments are passed through the wound.

FIGS. 5-9 and 14-16 illustrate a wound retractor 500 having a rollerdesign in accordance with another embodiment of the invention. The woundretractor 500 comprises an outer ring 502, an inner ring 504, and adistensible sleeve 506 connecting the outer ring 502 and the inner ring504. The sleeve 506 can be attached to the outer ring 502 and the innerring 504 by heat seal or adhesive. The outer ring 502 includes a hollowtube or lumen 508 that has a fan-like shape cross-section as illustratedin FIG. 5. The outer ring 502 further comprises an inner rod 510 thathas a similar fan-like geometry on its outer surface as illustrated inFIG. 6. The hollow tube 508 and the inner rod 510 are coaxially joinedto form the outer ring 502 of the wound retractor 500.

The fan-like geometry of the outer ring 502 serves as an incrementalrotating mechanism. In particular, when the hollow tube 508 is manuallyrolled out of its coaxial alignment with respect to the inner rod 510,the hollow tube 508 will index itself until it matches the nextalignment point of the inner rod 510 as illustrated in FIG. 8. When thehollow tube 508 and the inner rod 510 are coaxially aligned, they lockin place preventing further indexing until the steps of retracting arerepeated. It is appreciated that each of the hollow tube 508 and theinner rod 510 has at least one alignment point providing indexing andincremental rotation of the outer ring 502. That is, the outer ring 502can incrementally retract in steps based on the number of alignmentpoints or indexes on the fan.

FIG. 9 illustrates a process of installing the wound retractor 500 in awound opening 900. An incision in the shape of a slit is first made in apatient's body, e.g., the abdominal wall. The inner ring 504 and thesleeve 506 are then manually inserted and positioned underneath andalong the edges of body cavity wall 512, and the outer ring 502 ispulled through the wound opening 900 so as to be placed outside the bodycavity wall 512. Retraction of the sleeve 506 can then be achieved byrolling the outer ring 502 over the sleeve 506 in a direction 700 asshown in FIG. 7 until a desired compression or wound opening isachieved. Incremental retraction is achieved by manually rolling thehollow tube 508 out of its coaxial alignment with the inner rod 510,i.e., the hollow tube 508 can be rolled and indexed to match the nextalignment point between the hollow tube 508 and the inner rod 510.

When the hollow tube 508 and the inner rod 510 are coaxially aligned,they lock in place preventing further indexing until the outer ring 502is rolled out of its alignment again. This process is repeated until adesired retraction is achieved. Once surgery is complete, the woundretractor 500 can be retrieved by grabbing the inner ring 504 and thesleeve 506 and pulling them through the wound opening 900.

It is appreciated that the outer ring can be designed in various shapesand sizes to achieve various retraction rates and/or to conform withdifferent body surfaces as illustrated in FIGS. 17 a-17 e. For example,the outer ring may comprise a single or multiple tubes of differentshapes and sizes. The single or multiple tubes may be solid or includelumens of different shapes and sizes.

Similarly, the wound retractor having the roller design could be ofvarious geometries. As illustrated in FIGS. 18 a-18 l, hollow tubes 508a-508 l and inner rods 510 a-510 l, respectively, of the outer ring mayhave different shapes and sizes and may contain multiple lockingmechanisms. For example, the inner rods 510 b-510 e and 510 l have solidrectangular cross-sections. In comparison, the inner rods 510 f-510 khave hollow circular cross-sections. The hollow tubes and inner rods maybe made of the same or different materials (e.g., soft and/or hard). Forexample, the inner rods may be rigid such as a wire or piece of metal,or they may be flexible such as an extension spring. The lumens of thehollow tubes 508 a-508 l may have cross-sections of different geometriessuch as fan-like geometry, circular, oval, circular with lumps,triangular, rectangular, any geometric shape with multiple sides, etc.Advantages of the above embodiments of the invention include improvedretraction adjustability and stability.

FIGS. 19 a-19 g illustrate cross-section views of additional embodimentsof the outer ring of the invention having generally prolatecross-sections. That is, the longer axis of the cross-section of theouter ring is generally parallel to axis E-E as illustrated in FIG. 19a. The outer ring can be turned around the axis E-E in either an outwardor inward direction 800 to roll up the sleeve (not shown). The outerrings of FIGS. 19 a-19 g provide tactile gripping and incrementalrolling of the sleeve about the rings. FIG. 19 b illustrates an outerring 190 having two straight chordal surfaces 190 a and 190 b that aregenerally parallel to the axis E-E. FIG. 19 c illustrates an outer ringhaving two straight chordal surfaces and two curved chordal surfaces.FIGS. 19 d-19 g illustrate outer rings having at least two curvedchordal surfaces.

FIGS. 20 a-20 g illustrate cross-section views of the outer rings ofFIGS. 19 a-19 g, respectively, further including at least one lumen ineach ring. The lumen may house an inner rod (not shown) that deflectsagainst the lumen wall providing an audible feedback to the user. Thelumen and inner rod may be of different geometries and sizes.

FIGS. 21 a-21 e illustrate cross-section views of additional embodimentsof the outer ring of the invention having generally oblatecross-sections. That is, the longer axis of the cross-section of theouter ring is generally perpendicular to axis G-G as illustrated in FIG.21 a. The outer ring can be turned around the axis G-G in either anoutward or inward direction 900 to roll up the sleeve (not shown). Theouter rings of FIGS. 21 a-21 e provide tactile gripping and incrementalrolling of the sleeve about the rings. FIGS. 21 b-21 e illustrate outerrings having at least two curved chordal surfaces.

FIGS. 22 a-22 e illustrate cross-section views of the outer rings ofFIGS. 21 a-21 e, respectively, further including at least one lumen ineach ring. The lumen may house an inner rod (not shown) that deflectsagainst the lumen wall providing an audible feedback to the user. Thelumen and inner rod may be of different geometries and sizes.

FIG. 23 a illustrates a cross-section view of another embodiment of theouter ring of the invention having a triangular cross-section, and FIG.23 b illustrates a cross-section view of the outer ring of FIG. 23 afurther including a lumen. In another embodiment of the invention, FIG.24 a illustrates a cross-section view of the outer ring of the inventionhaving an odd number of sides such as a pentagon, and FIG. 24 billustrates a cross-section view of the outer ring of FIG. 24 a furtherincluding a lumen. These outer rings provide tactile gripping andincremental rolling of the sleeve about the rings. The lumens of theouter rings in FIGS. 23 b and 24 b may be of different shapes and sizesto house inner rods (not shown) having different shapes and sizes. It isappreciated that the outer ring can be designed in various shapes andsizes to achieve various retraction rates and/or to conform withdifferent body shapes.

FIGS. 25 a-25 b illustrate different processes of forming the outer ringof the invention. The outer ring, which may be solid or include a lumen,may be molded as a circular ring as shown in FIG. 25 a, or the outerring may be formed by joining a single or multiple extruded tubes into acircular ring as shown in FIG. 25 b.

In another embodiment of the invention, access into and out of apatient's body is achieved by a hand assisted laparoscopic (HAL)procedure using a surgical access device such as the Gelport™ device asdescribed in applicant's international application PCT/US01/29682, filedon Sep. 21, 2001, entitled “Surgical Access Apparatus and Method,” whichis incorporated herein by reference, while retraction is provided by thewound retractor of the present invention. The purpose of this embodimentis to combine the features and advantages of both the wound retractor ofthe present invention and the surgical access device as described in thePCT application. As explained in the PCT application, the currentsurgical access device uses a polyisoprene sheath that is wrappeddistally around an O-ring, and once placed into a wound incision, thesheath is then stretched over extended tabs onto an abdominal base. Thesheath of the surgical access device requires stretching and often timesrequires multiple attempts to secure it to the abdominal base. A noveltyof this embodiment is to modify the cap and/or the abdominal base of thesurgical access device so that it will accept the wound retractor of thepresent invention to replace the polyisoprene sheath and to maintain anairtight seal. The use of the wound retractor would simplify the HALprocedure and would not require stretching.

Referring to FIG. 26, there is shown a surgical access device 1000 withslight or moderate modifications to a gel cap 1010 and to an abdominalbase 1020. The gel cap 1010 further includes a gel pad 1030 and acircumferential cap ring 1040, which can be inserted and molded to thepad 1030. The resulting gel cap 1010 forms a seal with the base 1020,thereby defining a working channel through the pad 1030, the cap ring1040, the base 1020, and the sleeve 106 of the wound retractor. In thismanner, the working channel includes a single valve formed by the gelpad 1030 which provides both a zero seal and an instrument seal for awide range of instrument diameters. Referring to FIG. 27, thecross-section view of gel cap 1010 a illustrates an annular void 1042 athat is formed on the inner circumference of cap ring 1040 a. This voidis of particular advantage in forming a sealing relationship with base1020 a. FIGS. 28-30 illustrate additional exemplary embodiments of theinvention having modifications that could be made to the gel cap and/orthe abdominal base so that the surgical access device can be used withthe wound retractor.

FIG. 31 illustrates a perspective view of a base 1020 e in accordancewith another embodiment of the invention. FIG. 32 is an axialcross-section view of the embodiment illustrated in FIG. 31. From theseviews, it will be noted that the base 1020 e can be provided with asmooth generally cylindrical inner surface 1022 e which extendsproximally to a rounded end surface 1024 e and outwardly from the endsurface 1024 e along an annular lip 1026 e, which is sized andconfigured to fit into an annular void formed on the inner circumferenceof a corresponding cap ring. Proximally of the inner surface 1022 e, thebase 1020 e can also include a rounded end surface 1028 e along itsinner diameter for securing the outer ring of the wound retractor oncethe sleeve has been shortened.

In another embodiment of the invention, FIGS. 33 and 34 illustrate abase 1020 f having a smooth generally cylindrical inner surface 1022 f,a rounded end surface 1024 f, an annular lip 1026 f, and an end surface1028 f having at least one toggle or latch 1029 f sized and configuredto fit a corresponding cap ring. In this embodiment, the toggle or latch1029 f operates to change the inner diameter of the cap ring to create aseal or release the cap ring from the base. In yet another embodiment ofthe invention, FIGS. 35 and 36 illustrate a base 1020 g having a smoothgenerally cylindrical inner surface 1022 g, a rounded end surface 1024g, an annular lip 1026 g, and an end surface 1028 g having a raised wallsized and configured to fit a corresponding cap ring.

An advantage associated with the modified surgical access device is itenables a surgeon to quickly retract and protectively line an abdominalwall incision while being able to easily accommodate variations frompatient to patient in the thickness of the abdominal wall. In addition,the device effectively seals around the interior and exterior of theincision, and allows a sealing cap to be attached to seal the abdominalcavity and to enable a laparoscopic procedure to be performed.

Many alterations and modifications may be made by those having ordinaryskill in the art without departing from the spirit and scope of theinvention. For these reasons, the above description should not beconstrued as limiting the invention, but should be interpreted as merelyexemplary of preferred embodiments.

1. An adjustable wound retractor adapted to dilate a surgical woundincision to a desired diameter, comprising: a first ring having adiameter greater than the desired diameter of the wound incision andbeing adapted for disposition interiorly of the wound incision; a secondring having an annular axis and a diameter greater than the desireddiameter of the wound incision and being adapted for dispositionexteriorly of the wound incision; and a flexible sleeve disposed in agenerally cylindrical form between the first ring and the second ring,wherein the second ring may be rolled over itself and around the annularaxis to provide the sleeve with a radial retraction force sufficient tostretch the incision to the desired diameter.
 2. The wound retractor ofclaim 1, wherein the retractor is incrementally adjustable to fit a widerange of incision sizes.
 3. The wound retractor of claim 1, wherein thesecond ring has elastomeric properties enabling it to roll over itselfto provide a desired retraction force.
 4. The wound retractor of claim1, wherein any portion of the flexible sleeve extending outside thewound incision can be wrapped around the second ring to tightly seal thesides of the wound incision.
 5. The wound retractor of claim 1, whereinthe second ring is shaped to provide at least one of audible and tactilefeedback to a user.
 6. The wound retractor of claim 5, wherein thesecond ring includes surfaces that are easy to grip and turn allowingthe user to roll up the flexible sleeve with ease.
 7. The woundretractor of claim 1, wherein the second ring includes a lumen havingtubing wall.
 8. The wound retractor of claim 7, further comprising a rodplaced inside the lumen to deflect against the tubing wall to provide anaudible signal to a user as the second ring is rolled or turned overitself.
 9. The wound retractor of claim 1, wherein the sleeve is made ofa material that is flexible and impermeable to fluids and bacteria. 10.The wound retractor of claim 1, wherein the second ring comprises adouble-tube joined by a web.
 11. The wound retractor of claim 10,wherein each of the tubes of the double-tube is circular.
 12. The woundretractor of claim 11, wherein each of the tubes of the double-tube issolid or includes a lumen.
 13. The wound retractor of claim 10, whereinthe shape of the double-tube provides for an easy snap-action whenrolled about the annular axis.
 14. The wound retractor of claim 8,wherein the rod is a stainless steel wire.
 15. The wound retractor ofclaim 8, wherein the rod further provides retraction stability to thewound retractor.
 16. The wound retractor of claim 7, further comprisinga unidirectional mechanism for retaining the second ring at one of aplurality of positions in order to provide a desired radial retractionforce associated with that position.
 17. The wound retractor of claim16, wherein the unidirectional mechanism includes a one-way roller. 18.The wound retractor of claim 8, wherein the lumen has a fan-like shapecross-section.
 19. The wound retractor of claim 18, wherein the rod hasa fan-like cross-section and is coaxially placed inside the lumen toserve as an incremental rotating mechanism of the wound retractor. 20.The wound retractor of claim 8, wherein each of the tubing wall and therod includes a plurality of alignment points that operate to index andmatch each other as the second ring is rolled out of and into alignmentwith respect to the rod.
 21. The wound retractor of claim 8, whereineach of the tubing wall and the rod includes at least one alignmentpoint providing indexing and incremental rotation of the second ring.22. The wound retractor of claim 7, wherein the lumen of the second ringhas a cross-section including circular, oval, circular with at least onelump, rectangular, triangular, and any geometric shape with multiplesides.
 23. The wound retractor of claim 8, wherein the rod has across-section including solid rectangular, hollow rectangular, solidcircular, hollow circular, and any solid or hollow geometric shape. 24.The wound retractor of claim 1, wherein the second ring has a generallyprolate cross-section.
 25. The wound retractor of claim 1, wherein thesecond ring can be rolled in either an outward or inward direction toroll up the sleeve.
 26. The wound retractor of claim 24, wherein thesecond ring comprises two generally straight chordal surfaces parallelto the annular axis.
 27. The wound retractor of claim 26, wherein thesecond ring further comprises two opposing curved chordal surfaces. 28.The wound retractor of claim 24, wherein the second ring comprises atleast two curved chordal surfaces.
 29. The wound retractor of claim 24,wherein the second ring includes at least one lumen having tubing wall.30. The wound retractor of claim 29, further comprising a rod placedinside the lumen to deflect against the tubing wall to provide anaudible signal to a user as the second ring is rolled or turned overitself.
 31. The wound retractor of claim 29, wherein the lumen of thesecond ring has a cross-section including circular, oval, circular withat least one lump, rectangular, triangular, and any geometric shape withmultiple sides.
 32. The wound retractor of claim 30, wherein the rod hasa cross-section including solid rectangular, hollow rectangular, solidcircular, hollow circular, and any solid or hollow geometric shape. 33.The wound retractor of claim 1, wherein the second ring has a generallyoblate cross-section.
 34. The wound retractor of claim 33, wherein thesecond ring comprises at least two curved chordal surfaces.
 35. Thewound retractor of claim 33, wherein the second ring includes at leastone lumen having tubing wall.
 36. The wound retractor of claim 35,further comprising a rod placed inside the lumen to deflect against thetubing wall to provide an audible signal to a user as the second ring isrolled or turned over itself.
 37. The wound retractor of claim 35,wherein the lumen of the second ring has a cross-section includingcircular, oval, circular with at least one lump, rectangular,triangular, and any geometric shape with multiple sides.
 38. The woundretractor of claim 36, wherein the rod has a cross-section includingsolid rectangular, hollow rectangular, solid circular, hollow circular,and any solid or hollow geometric shape.
 39. A surgical access devicefacilitating a sealing relationship with an instrument extending throughthe device and into an incision, the access device comprising: a firstring being adapted for disposition interiorly of the incision; a secondring having an annular axis and being adapted for disposition exteriorlyof the incision; a flexible sleeve connecting the first ring and thesecond ring and having properties to roll over itself and around theannular axis to shorten the sleeve in predetermined increments; and avalve structure disposed relative to the incision to securely receivethe second ring.
 40. The surgical access device of claim 39, wherein therolling properties of the second ring provide the sleeve with a radialretraction force sufficient to stretch the incision to a desireddiameter.
 41. The surgical access device of claim 39, wherein the valvestructure comprises a gel cap and an abdominal base.
 42. The surgicalaccess device of claim 41, wherein the gel cap further comprises a gelpad and a circumferential cap ring.
 43. The surgical access device ofclaim 42, wherein the cap ring has an annular void on an innercircumference to form a sealing relationship with the abdominal base.44. The surgical access device of claim 41, wherein the abdominal basecomprises a rounded end surface along its inner diameter to secure thesecond ring.
 45. The surgical access device of claim 41, wherein theabdominal base comprises a plurality of toggles along its inner diameterto create a seal with the cap or to release the base from the cap. 46.The surgical access device of claim 41, wherein the abdominal basecomprises a plurality of latches along its inner diameter to create aseal with the cap or to release the base from the cap.
 47. The surgicalaccess device of claim 41, wherein the abdominal base comprises a matingmeans along its inner diameter to create a seal with the cap or torelease the base from the cap.
 48. The surgical access device of claim41, wherein the abdominal base comprises a raised wall along its innerdiameter to fit a corresponding cap ring.
 49. The surgical access deviceof claim 39, wherein the valve structure forms a pad adapted to bedisposed over the incision and forms a seal around the incision, the padincludes a gel material having portions defining an access channelthrough the pad and extending into communication with the incision. 50.The surgical access device of claim 39, wherein the instrument comprisesan arm of a surgeon.
 51. A method for operating an adjustable woundretractor, comprising: providing a flexible sleeve having a first endattached to a first ring and a second end attached to a second ring,said second ring having properties to roll over itself and around anannular axis to shorten the sleeve in predetermined increments;inserting the first ring and the sleeve into a patient's body cavity soas to provide a channel from the outside to the inside of the patient'sbody; drawing the second end of the sleeve upwards and radially outwardor inward thereby drawing the first ring tightly against the innersurface of the body cavity, and thereby retracting the adjacent tissueand producing a tightly sealed opening in the body cavity; and rollingthe sleeve by gripping the second ring and turning it around the annularaxis in either an outward or inward direction until the sleeve abuts theouter edge of the wound incision.
 52. The method of claim 51, furthercomprising the step of grabbing the first ring and the sleeve andpulling them through the wound opening after surgery.
 53. The woundretractor of claim 1, wherein the second ring is formed from at leasttwo generally circular tubes providing different annular lock pointsaround the annular axis.
 54. The wound retractor of claim 53, whereineach of the tubes is solid or includes a lumen having tubing wall. 55.The wound retractor of claim 54, further comprising a rod placed insideat least one of the lumen of the tubes to deflect against the tubingwall to provide an audible signal to a user as the second ring isrotated.
 56. The wound retractor of claim 53, wherein the number oftubes forming the second ring determines the number of lock pointsaround the annular axis.